Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-01-01 @ 8:08 PM
Study NCT ID:
NCT03277859
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2017-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI)
Sponsor:
VA Eastern Colorado Health Care System
Organization:
Study Overview
Official Title:
Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI)
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAA-TBI
Brief Summary:
The specific aims of the proposed study are to evaluate: 1) the feasibility of design elements of a Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI) intervention trial (e.g., an exercise run-in to facilitate participant retention); 2) yoga instructor fidelity; and 3) variability estimates for candidate proximal and distal outcomes. Performance of validated measures, including those associated with quality of life, as well as data collected via ecological momentary assessment and pedometry (physical activity) will be evaluated.
Detailed Description:
A signature injury being sustained by Veterans from recent conflicts is mild traumatic brain injury (mTBI). For some, this condition is associated with multiple disabling post-concussive symptoms, including post-concussive headaches (PCH). PCHs are notoriously resistant to medication alone, and are associated with increased muscle tension, avoidance of physical activities, and anxiety related to having chronic pain. In this study, the feasibility (ease of implementation) of the design elements of an interventional trial of Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI) will be explored. Yoga is operationalized as a practice involving physical postures, breath awareness, breathing exercises and mindfulness meditation. It is conceptualized as having three "active ingredients" (i.e., regulation of the autonomic nervous system via physical activity/breathing exercises, release of muscular tension associated with headaches, and mindfulness/acceptance). The specific aims of the proposed study are to evaluate: 1) the feasibility of design elements of an SAA-TBI intervention trial (e.g., an exercise run-in to facilitate participant retention); 2) yoga instructor fidelity; and 3) variability estimates for candidate proximal and distal outcomes. Performance of validated measures, including those associated with quality of life, as well as data collected via ecological momentary assessment and pedometry (physical activity) will be evaluated. Project aims will be evaluated using an experimental design where participants will be block randomized in a stratified manner to SAA-TBI or a waitlist using a 1:1 ratio. The waitlist group will initially receive 8 weeks of enhanced treatment as usual (ETU). The participants in the waitlist condition will be offered SAA-TBI, after the initial group has completed the intervention. Both groups of participants will complete multiple measures at baseline and after the conclusion of the intervention. Maintenance among the intervention group will also be explored. Participants will be asked to complete daily homework documenting their headaches and yoga practice outside of class, and be provided with multiple modalities (web-based, mobile app, text, or paper and pencil) by which this can be accomplished. In specific, the proposed study will evaluate the feasibility of the trial design for an accessible, non-pharmacological, yoga-based intervention for chronic PCH pain among Veterans with mTBI, with the long-term goal of informing future efficacy trials.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: